UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053435 |
|---|---|
| Receipt number | R000060981 |
| Scientific Title | Usefulness of the Perivascular Fat Attenuation Index in Acute Aortic Dissection: A Multicenter Observational Cohort Study |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/04/17 16:07:40 |
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Basic information
Public title
Usefulness of the Perivascular Fat Attenuation Index in Acute Aortic Dissection
Acronym
Fat attenuation index for acute aortic dissection
Scientific Title
Usefulness of the Perivascular Fat Attenuation Index in Acute Aortic Dissection: A Multicenter Observational Cohort Study
Scientific Title:Acronym
AIDFAI (Aortic Inflammation Detection using Fat Attenuation Index in Dissection) Study
Region
| Japan |
Condition
Condition
Acute aortic dissection
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the usefulness of the perivascular fat attenuation index in the diagnosis and risk stratification of patients with acute aortic dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis: The accuracy of the perivascular fat attenuation index in correctly diagnosing acute aortic dissection. Prognostication: The incidence of all-cause deaths and aortic events in patients with Stanford type B acute aortic dissection.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Regarding the diagnostic capability of the FAI, a retrospective, multicenter study was conducted involving consecutive patients from five institutions who underwent CT for chest or back pain. These institutions included the Department of Cardiovascular Medicine at the University of Tokyo Hospital (January 2018-June 2020), Sakakibara Heart Institute (January 2018-December 2021), Division of Cardiovascular Medicine at Saitama Medical Center, Jichi Medical University (May 2017-December 2021), Department of Cardiology at Tokyo Metropolitan Police Hospital (January 2019-December 2022), and Department of Cardiology at Kanto Central Hospital (January 2018-June 2021).
Key exclusion criteria
The patients who met the following criteria were excluded from the study: Patients with a previous history of AAD, trauma patients, individuals who did not undergo non-contrast CT, or those with poor image quality of scans due to implants or intra-aortic balloon pumping. Furthermore, individuals who were exposed to tube voltages other than 120 kVp were also excluded to maintain a consistent imaging protocol in the study. We excluded cases of aortic dissection limited to the ascending aorta, abdominal aorta, or aortic arch, as well as patients with aortic rupture and those who had undergone thoracic endovascular aortic repair (TEVAR). For the prognostic evaluation, the focus was on patients with type B AAD. Patients who underwent surgical interventions, including TEVAR and total arch replacement during their hospital stay, were excluded. Patients who died or experienced recurrent dissection during the same index hospitalization were also excluded, along with those who did not undergo follow-up CT during their hospitalization.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Adachi |
Organization
The University of Tokyo
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo, Tokyo, Japan
TEL
+81-3-3815-5411
yuadachi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Adachi |
Organization
The University of Tokyo
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
yuadachi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
The University of Tokyo
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo, Tokyo, Japan 113-0033
Tel
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this study is to evaluate the usefulness of the perivascular fat attenuation index in the diagnosis and risk stratification of patients with acute aortic dissection. This observational study will involve retrospectively analyzing patient data from multiple centers. It will focus on comparing FAI values obtained from non-contrast computed tomography scans in patients diagnosed with acute aortic dissection versus those without the condition. Additionally, the study will observe the correlation between FAI values and the incidence of adverse outcomes in these patients to assess its prognostic value.
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060981
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